Description
Tenofovir Disoproxil Fumarate Tablets (300 mg)
Healthy Inc is a globally recognized supplier of advanced antiviral and antiretroviral therapies. We provide premium Tenofovir Disoproxil Fumarate (TDF) Tablets, manufactured in WHO–GMP certified, high-containment antiviral units. As a first-line treatment for viral management, this product is a primary export for HIV/AIDS clinics, hepatology centers, and National Health Tenders in Africa, Southeast Asia, and Eastern Europe.
Product Overview
Tenofovir Disoproxil Fumarate is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. It is an acyclic nucleoside phosphonate diester analog of adenosine monophosphate, specifically engineered for high oral bioavailability and potent viral suppression.
The “Double-Target” Antiviral Specialist:
- Mechanism of Action: TDF is a prodrug that is intracellularly converted to Tenofovir Diphosphate. This active metabolite competes with the natural substrate (deoxyadenosine 5’-triphosphate) for viral Reverse Transcriptase (in HIV) and DNA Polymerase (in HBV), leading to DNA chain termination and inhibition of viral replication.
- High Barrier to Resistance: Tenofovir is characterized by a high genetic barrier, making it an essential component of Highly Active Antiretroviral Therapy (HAART) and a preferred monotherapy for Chronic Hepatitis B.
- Pharmacokinetic Profile: With a long intracellular half-life, TDF supports simple once-daily dosing, significantly improving long-term patient adherence in chronic disease management.
Technical & Manufacturing Specifications
Formulated for maximum stability and precise molecular integrity.
| Technical Metric | Specification Standard |
|---|---|
| Active Ingredient | Tenofovir Disoproxil Fumarate BP / USP / IP |
| Dosage Form | Film-Coated Tablets |
| Standard Strength | 300 mg (equivalent to 245 mg of tenofovir disoproxil) |
| HS Code | 3004.90.99 (Antiviral Medicaments) / 2933.39.19 |
| Packaging | HDPE Bottles with child-resistant caps and desiccants |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from specialized ISO 9001:2015 units.
- Moisture-Sensitive Processing: TDF is highly susceptible to hydrolysis. Our manufacturing process utilizes low-humidity environments (RH < 30%) and specialized moisture-protective film coating to ensure the product meets strict impurity limits (specifically the monoester and dimer impurities).
- Bioequivalence Standards: Every batch is validated against the innovator profile (Viread) to ensure identical pharmacokinetic parameters, crucial for maintaining undetectable viral loads.
- Dedicated Containment: Produced in dedicated ARV blocks to eliminate any risk of cross-contamination with other drug classes.
Therapeutic Indications & Clinical Symptoms
- HIV-1 Infection: Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients.
- Chronic Hepatitis B (HBV): Treatment of HBV in adults with compensated and decompensated liver disease.
- Pre-Exposure Prophylaxis (PrEP): Used in combination with Emtricitabine to reduce the risk of sexually acquired HIV-1 infection.
Dosage & Administration
- Adult Dose: One 300 mg tablet once daily.
- Administration: Can be taken with or without food, though absorption is slightly enhanced when taken with a high-fat meal.
- Renal Monitoring: Dosage interval adjustment is required for patients with creatinine clearance < 50 mL/min. Bone mineral density monitoring is also recommended for long-term users.
Global Export & Contract Manufacturing Services
Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to The Global Fund, USAID, and National AIDS Control Organizations (NACO). We offer Third Party Manufacturing for Tenofovir and its combinations (e.g., Tenofovir/Lamivudine/Dolutegravir) with full CTD Dossier support. Our logistics network ensures secure transit to Nigeria, South Africa, Vietnam, and Brazil, providing WHO-GMP quality at competitive B2B prices.
Commercial Inquiries
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
